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A Trusted News Partner For Early Startup Success
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In late 2025, the United States Food and Drug Administration (FDA) issued a formal warning letter to the Boston-based niche wearable tech company, WHOOP, known for its performance and recovery-focused wristbands. The FDA regulates certain health-focused tools in wearable devices such as smartwatches.
WHOOP positioned “Blood Pressure Insights” (BPI) as a wellness feature, a tool to help users to understand how blood pressure interacts with sleep, stress, and exercise, rather than a medical diagnostic tool. However, the FDA warned WHOOP, asserting that BPI functions provide a measurement of a user’s blood pressure, which is associated with the diagnosis of medical conditions such as hypertension.
According to the FDA’s regulatory framework and its warning letter, blood pressure monitoring is linked to health diagnoses because high and low readings can directly influence decisions around a user’s health. Even the product’s design and user interface, colour-coded ranges imply diagnostic intent.
Under U.S. law, a product is considered a medical device if it is intended for use in the diagnosis of disease or in the cure, mitigation, treatment, or prevention of disease. The FDA warned BPI that it is not eligible for the general wellness policy exemption.
WHOOP has publicly declined it, criticizing the FDA’s position as an overreach and reaffirming its commitment to the feature. The CEO of WHOOP, Will Ahmed, has defended BPI as a wellness tool rather than a medical device.
Wearable devices are equipped with sophisticated sensors that measure heart rate variability, blood oxygen levels, and respiratory patterns. However, regulators are now demanding that features capable of influencing health decisions receive formal FDA clearance.
The FDA’s scrutiny of WHOOP’s BPI feature is more than a dispute over one product. It reflects on a broader inflection point in the wearable technology industry. For niche wearable device manufacturers, this situation poses both challenges and opportunities. It presents challenges in navigating a more complex regulatory landscape. However, it has opportunities to differentiate through compliance with healthcare stakeholders.
The WHOOP case underscores the need for clearer guidance and ongoing dialogue between innovators and regulators.
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